申请企业

Baxalta US Inc.

药品名称

Aralast; Aralast NP, Alpha-1-Proteinase Inhibitor (Human)

状态

未解决

承诺描述

Contingent on the outcome of the pilot trial described in commitment 3, conduct and report the results of an adequately-powered study of clinically meaningful endpoints(s). Based on the results of the pilot study and the available scientific data at the time that this study is being designed, work with entities maintaining registries of alpha1-proteinase inhibitor deficient patients and with the National Institutes of Health (NIH) to design and conduct an adequately-powered study of a clinically meaningful endpoint(s). The study design could involve a single product or could potentially involve a cooperative simultaneous study of multiple products in parallel arms, using a factorial design.

承诺状态描述

报告接收日期

2021/2/18 0:00:00

批准日期

2002/12/23 0:00:00

截止日期

2024/7/31 0:00:00

CDER/CBER

CB

子类型标记